Case Medical Evaluator in Bridgewater, New Jersey! 3020468

**Contractors will be working on SINGLE CASES. There are 2 positions. Prefers someone with CME experience or someone who has freshly completed medical residency in the United States. May consider someone who has completed residency outside of the US.

RESPONSIBILITIES:

- Medical expert in the Case Management Pharmacovigilance Unit for assigned products.

- Medical evaluation of all adverse events for assigned products.

- Participate to signal detection for assigned products.

- Prompt identification and immediate communication of potential alert reports and safety signals to the Global Safety Officer.

- Individual Case Reviews: For assigned products, reviews all individual adverse event reports for clinical and regulatory assessment. Directs follow-up for serious cases. Approval of all individual case reports to regulatory authorities (all serious/listed/(associated) cases). Identify all SUSAR cases for prompt review by GSO. Identification of potential safety signals and informing Global Safety Officer of all potentially-important cases and issues.

- Aggregate safety data review: For assigned products, ongoing global clinical overview of all adverse event reports, including review of relevant literature for safety information pertinent to product safety, detection of potential safety signals, periodic review/documentation of all safety data.

- Clinical: assesses cases for clinical implication, enters company case evaluation comment into Clintrace, directs follow-up with relevant units (ASO, URC ?).

- Supports signal detection/analysis activities with Global Safety Officer.

- Maintain clinical knowledge in assigned therapeutic areas, and knowledge of international safety regulations.

- Ensure literature surveillance for assigned products.

- Coordination of safety activities within CMPU for assigned products : serves as expert for documentation, quality of cases, PTC evaluation, DEUP cases.

- Interacts with GPE colleagues, clinical teams and ASOs.

REQUIREMENTS:

- MD or PharmD degree preferred.

- At least 3 years in Pharmacovigilance, or related experience, preferred.

- Excellent teamwork and interpersonal skills.

- Good clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way effectively.

- Initiative and capability to work under pressure.

- Procedures and guidelines SOPs, Working practices).

- Database (Clintrace).